Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

NCT ID: NCT04217759

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-02-27

Brief Summary

The general research question posed was 'How effective is a healthy lifestyle intervention using behavioural change strategies in the prevention of Type 2 Diabetes Mellitus (T2DM)?'.

The main aim was to assess the effectiveness of a healthy lifestyle intervention implemented for 12 weeks via face-to-face group sessions and by using social media tools (Facebook and WhatsApp) for young adults at risk of T2DM.

The hypothesis was that this healthy lifestyle intervention may be effective in terms of initiating an increased physical activity (PA) level and a healthy balanced dietary intake resulting in improvements of other T2DM risk factors at 12 weeks.

Detailed Description

The specific research question posed was 'Is a healthy lifestyle intervention using Social Cognitive Theory (SCT)-based PA and dietary strategies implemented for 12 weeks through face-to-face group sessions and social media tools effective in the initiation and maintenance of increased PA level and healthy balanced dietary intake, resulting in improvements of T2DM risk score, anthropometrics, metabolic parameters and SCT-related psychosocial factors among Bruneian young adults at risk of T2DM?'.

Study design was two-arm parallel, stratified with simple randomisation, and assessor-blinded randomised controlled trial. Participants were randomly allocated into intervention group and control group. Participants were students and alumni of Universiti Brunei Darussalam and Universiti Teknologi Brunei who were overweight-obese at risk of T2DM with a mean age of 23.1 (2.48) years old. Intervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks, while the control group only received leaflets on healthy lifestyle with no further guidance. Outcomes measured were changes from baseline at week 0 to post-intervention at week 13 between intervention and control groups. Outcomes were changes in diabetes risk score, anthropometrics, metabolic parameters, PA, dietary intake and SCT-related psychosocial factors, with repeated-measures ANOVA as the main analysis.

Conditions

Overweight and Obesity; Risk Reduction; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Intervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks via face-to-face sessions and social media tools (Facebook and WhatsApp)

Group Type: EXPERIMENTAL

Healthy lifestyle intervention

Intervention Type: BEHAVIORAL

The main goal was to provide knowledge and skills for targeted population in order for them to adapt healthy lifestyle throughout their life. At the end of intervention, participants were expected to be fully equipped with necessary knowledge and fundamental skills in adapting and maintaining healthy lifestyle throughout their life. Gradual improvements were emphasised and at least 5% loss of initial body weight was expected, aiming for at least 0.5% loss in the first month.

It was divided into three phases (preparation, implementation, maintenance) focusing on PA and diet, in which self-efficacy enhancement and self-regulatory skills were emphasised during the first month of intervention.

Control group

Control group only received leaflets on healthy lifestyle with no further guidance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy lifestyle intervention

The main goal was to provide knowledge and skills for targeted population in order for them to adapt healthy lifestyle throughout their life. At the end of intervention, participants were expected to be fully equipped with necessary knowledge and fundamental skills in adapting and maintaining healthy lifestyle throughout their life. Gradual improvements were emphasised and at least 5% loss of initial body weight was expected, aiming for at least 0.5% loss in the first month.

It was divided into three phases (preparation, implementation, maintenance) focusing on PA and diet, in which self-efficacy enhancement and self-regulatory skills were emphasised during the first month of intervention.

Intervention Type: BEHAVIORAL

Other Intervention Names

Be Healthy Camp

Eligibility Criteria

Inclusion Criteria

• Bruneian including permanent residents
• BMI from 25.00 to 39.99 kg/m2
• American Diabetes Association (ADA) diabetes risk score of at least 3 and maximum score of 8
• Mentally and physically fit with no chronic conditions
• Without medical conditions that could influence glucose metabolism and insulin resistance
• Answered 'No' to all 6 questions in questionnaire-based pre-exercise risk assessment
• Not actively participating in other healthy lifestyle programmes
• Had access to computer or mobile phone with Internet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Brunei Darussalam

OTHER

Sponsor Role: lead

Responsible Party

Alifah Nur'ain Haji Mat Rasil

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alifah Nur'ain Haji Mat Rasil

Role: PRINCIPAL_INVESTIGATOR

University Brunei Darussalam

Locations

PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam

Brunei, Bandar Seri Begawan, Brunei

Countries

Brunei

Other Identifiers

UBDIHS/13H0621

Identifier Type: -

Identifier Source: org_study_id